Comparison of the Effectiveness of Two Different Surgical Therapeutic Protocols of Peri-implantitis

NARecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

July 28, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Peri-ImplantitisPeri-Implant Health
Interventions
PROCEDURE

Non-surgical peri-implant therapy

"2 weeks after baseline examination, non surgical therapy will be applied in implants diagnosed with peri-implantitis prior to enrollment in surgical therapy.~Firstly, participants will be instructed in oral hygiene. Professional supragingival and subgingival debridement of implants/ teeth, including the selected for the study implants, will be performed. Local anesthesia will be performed, when needed. Targeted implants will be treated with PEEK-coating ultrasonic tips (Instrument PI; EMS), titanium curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy), rubber cup and polishing paste. Possible adjustments to implant-borne prostheses will be considered, whenever possible. Re-evaluation of non-surgical therapy will be performed after 6 weeks.~At the 6-week reevaluation, participants with peri-implant probing pocket depth ≥5 mm and bleeding on probing and/or suppuration in patients with full mouth plaque score ≤20% will proceed to surgical therapy."

PROCEDURE

Implantoplasty

"Screw-retained supraconstructions and, when possible, cement-retained restorations will be removed.~Following local anesthesia, intrasulcular incisions will be performed and full-thickness flaps will be elevated on the buccal and lingual aspects of affected implants. Granulation tissue will be removed, and titanium-coated curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy) and NiTi brushes (NEGRIN IN DENTAL) will be applied to remove hard deposits on implants. Osseous recontouring will be performed when indicated followed by irrigations with saline. Implantoplasty will be applied using tungsten carbide burs of various shapes and sizes (Peri-implantitis Kit; Meisinger) followed by irrigations with saline. Flaps will be readjusted and closed with sutures in order to allow a non-submerged healing. Supraconstructions will be reconnected after the surgery."

PROCEDURE

Erythritol Air-abrasive device

"Screw-retained supraconstructions and, when possible, cement-retained restorations will be removed.~Following local anesthesia, intrasulcular incisions will be performed and full-thickness flaps will be elevated on the buccal and lingual aspects of affected implants. Granulation tissue will be removed, and titanium-coated curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy), and NiTi brushes (NEGRIN IN DENTAL) will be applied to remove hard deposits on implants. Osseous recontouring will be performed when indicated followed by irrigations with saline. Implant surface decontamination with an air-abrasive device (AIRFLOW® MAX, AIRFLOW® Prophylaxis Master; EMS) with erythritol powder (AIRFLOW® Plus Powder; EMS) will be applied followed by irrigations with saline. Flaps will be readjusted and closed with sutures in order to allow a non-submerged healing. Supraconstructions will be reconnected after the surgery."

PROCEDURE

Prophylaxis

Supramucosal biofilm removal of implants/ teeth will be performed at, 3, 6, 9 and 12 months after surgical therapy for the Implantoplasty group and the Erythritol Air-abrasive device group and at 2 weeks, 3, 6, 9 and 12 months after baseline examination for the control group. Targeted implants will be treated with an air-abrasive device (AIRFLOW® MAX, AIRFLOW® Prophylaxis Master; EMS) with erythritol powder (AIRFLOW® Plus Powder; EMS). During these appointments, patients will be re-motivated and re-instructed to oral-hygiene measures.

Trial Locations (1)

11527

RECRUITING

Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens, Athens

All Listed Sponsors
lead

National and Kapodistrian University of Athens

OTHER